Easy@Home Wireless TENS Pulse Massager

GUDID 10850253007762

EASY HEALTHCARE CORPORATION

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• Primary Device ID: 10850253007762
• NIH Device Record Key: c266c1e2-d505-4bc1-9089-cc404b4cff61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Wireless TENS Pulse Massager
• Version Model Number: EHE016
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850253007765 [Primary]
GS1	10850253007762 [Package]; Contains: 00850253007765; Package: Carton [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141260

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-26
• Device Publish Date: 2016-12-09

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